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Dignitana AB

US

Last updated September 17, 2026

Information

Country
US
Address
10925 Estate Lane, Dallas, TX, 75238
Website
dignitana.com
LinkedIn
—
Facebook
—
Phone
4646163090
PRRC Contact
—
EUDAMED SRN
—
FDA FEI Number
3012146457
DUNS Number
775901619

Catalogue (31)

DeviceModel / ReferenceRegistriesClassStatus
DigniCap® Delta 800-1103
FDA UDI
Class IIActive
DigniCap S1
FDA UDI
N/AUnknown
DigniCap L2
FDA UDI
Class IIUnknown
DigniCap® Delta 800-1004
FDA UDI
Class IIActive
DigniCap M2
FDA UDI
Class IIUnknown
DigniCap® Delta 800-2003
FDA UDI
Class IIActive
DigniCap® Delta 800-1003
FDA UDI
Class IIActive
DigniCap® Delta 800-1104
FDA UDI
Class IIActive
DigniCap® Delta 700-1001
FDA UDI
Class IIActive
DigniCap® Delta 800-1201
FDA UDI
Class IIActive
DigniCap® Delta 900-1001
FDA UDI
Class IIActive
DigniCap M1
FDA UDI
Class IIUnknown
DigniCap® Delta 700-1005
FDA UDI
Class IIActive
DigniCap S2
FDA UDI
Class IIUnknown
DigniCap® Delta 800-1102
FDA UDI
Class IIActive
DigniCool 0.5L
FDA UDI
Class IIUnknown
DigniCap® Delta 800-1001
FDA UDI
Class IIActive
DigniCap® Delta 800-2001
FDA UDI
N/AActive
DigniCap XS1
FDA UDI
Class IIUnknown
DigniCap® Delta 800-2002
FDA UDI
Class IIActive
DigniCap® Delta 700-1004
FDA UDI
Class IIActive
DigniCap® Delta 700-1002
FDA UDI
Class IIActive
DigniCap® Delta 700-1006
FDA UDI
Class IIActive
DigniCap® Delta 800-1002
FDA UDI
Class IIActive
Digni C3 C3 - 115 VAC
FDA UDI
Class IIUnknown
DigniCap® Delta 900-2001
FDA UDI
Class IIActive
DigniCap® Delta 700-1003
FDA UDI
Class IIActive
DigniCool 5L
FDA UDI
Class IIUnknown
DigniCap Scalp Cooling System K170871
FDA 510(k)
Class IIActive
DigniCap Delta K191166
FDA 510(k)
Class IIActive
Dignitana AB DigniCap System DEN150010
FDA 510(k)
Class IIActive

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

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Notified Bodies

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Authorities

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FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

  • Dignitana Ab Lund Skane · SE FEI 3008888703